| Methods |
Concealment: numbered pharmacy
Blinding: double‐blind
Drop‐outs/withdrawals: none
Jadad score: 2‐2‐1
IV score: 1‐1‐1‐1‐1‐1 |
| Participants |
Patients included/analyzed: 72/72
Demographics: 48 female, mean age 48 years
Diagnosis: mild to moderate depression (DSM‐IV 296.21/31/22/32)
Setting: 11 practices (psychiatry, internal medicine, GP) in Germany
Baseline: HAMD score 19.7 +/‐ 3.4 hpyericum group, 20.1 +/‐ 2.6 placebo group |
| Interventions |
Treatment: Hypericum extract WS 5572 (Neuroplant) 3x1 coated tablet (900 mg) for 6 weeks
Control: Placebo for 6 weeks |
| Outcomes |
Observation period: 3‐7 days run‐in, 6 weeks treatment
Physician‐rated: Hamilton Depression Scale (HAMD, 17 items; response = at least 50% reduction), Clinical Global Impression Index (CGI)
Patient‐rated: von Zerssen Depression Scale (D‐S), Patient's Global Assessment Scale (GPA) |
| Notes |
Trial with adaptive design stopped early due to significant superiority at preplanned interim analysis |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
